Month: June 2018

China continues its massive update of Medtech standards Brandwood Biomedical Global Medical Device and IVD Regulatory Services

China continues its massive update of Medtech standards

China is continuing its efforts to modernise the national technical standards infrastructure. Back in 2015, CFDA announced a plan to bring forward a complete update of technical standards, with the...
Australia Removes Two-Year Clinical Evidence Rule for Reimbursement Brandwood Biomedical Global Medical Device and IVD Regulatory Services

Australia Removes Two-Year Clinical Evidence Rule for Reimbursement

Australian sponsors of implantable medical devices have at times been frustrated by a requirement of two years of clinical evidence for ‘high-risk’ devices. This rule has typically been applied to...
TGA introduces new Class Device application Fee, plus general 1.9 percent increase. Brandwood Biomedical Global Medical Device and IVD Regulatory Services

TGA introduces new Class I Device application Fee, plus general 1.9% increase.

In a long-anticipated change, TGA today announced the introduction of a new $530 application fee for Class I medical devices and an overall increase of 1.9% to most other TGA...
In these days of harmonisation and mutual recognition, who has the best device regulatory passport Brandwood Biomedical Global Medical Device and IVD Regulatory Services

In these days of harmonisation and mutual recognition, who has the best device regulatory passport?

It's almost 30 years since the establishment of the Global Harmonisation Task Force (GHTF), now replaced by the IMDRF.  The GHTF essentially produced guidances built on the European regulatory model...
This China regulatory change for IVDs will save up to 90% of clinical trial costs Brandwood Biomedical Global Medical Device and IVD Regulatory Services

This China regulatory change for IVDs will save up to 90% of clinical trial costs

China's CFDA exempts many devices and IVDs from requirements for clinical trials to support registration. Two weeks ago CFDA released their latest "4th Wave" of proposed clinical trial exemptions, which...
CFDAs 4th Wave exempts another 85 devices and 277 IVDs from Clinical Trials Brandwood Biomedical Global Medical Device and IVD Regulatory Services

CFDAs 4th Wave exempts another 85 devices and 277 IVDs from Clinical Trials

On June 11, 2018, CFDA released their latest proposals for medical device and IVD clinical trial exemptions covering another 85 devices and 277 IVDs. This proposed "4th wave" exemption list breaks...
Advice on change registration for applicants manufacturers Chinese name-brandwood-biomedical-global-expertise-medical-device-regulatory-compliance-australia-china-new-zealand

Advice on change registration for applicants & manufacturers’ Chinese name

On November 2, 2017, Chinese Food & Drug Administration (CFDA) released a new regulation which requires overseas applicants/manufacturers to include the standardized Chinese translation of company information within their applications....
Are Doctors Fees Threatening Private Health Insurance in Australia - brandwood-biomedical-global-expertise-medical-device-regulatory-compliance-australia-china-new-zealand

Are Doctor’s Fees Threatening Private Health Insurance in Australia?

Australia has a universal healthcare system (Medicare). There is also has a private health insurance option that covers admissions into private hospitals. It is understandable that most Australians who are...
TGA Determines 3D Proposed Changes still need work brandwood-biomedical-global-expertise-medical-device-regulatory-compliance-australia-china-new-zealand

TGA Determines 3D Proposed Changes still need work

In what was not a surprise based on the industry feedback, the Australian regulator of therapeutic goods (Therapeutic Goods Administration) will return to the drawing board with their proposed changes...

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